The following data is part of a premarket notification filed by Janco Polymers Pvt., Ltd. with the FDA for Zoetic Gloves.
Device ID | K905515 |
510k Number | K905515 |
Device Name: | ZOETIC GLOVES |
Classification | Latex Patient Examination Glove |
Applicant | JANCO POLYMERS PVT., LTD. PLOT NO. 18, EXPORT PROCESSING ZONE, KOCHI, KERALA, India, IN |
Contact | Joseph |
Correspondent | Joseph JANCO POLYMERS PVT., LTD. PLOT NO. 18, EXPORT PROCESSING ZONE, KOCHI, KERALA, India, IN |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-10 |
Decision Date | 1990-12-19 |